Study Demonstrates Clinical Equivalence of Biosimilar Candidate ABP 501 and Humira

Amgen presented detailed findings from a comparative study comparing the safety, effectiveness and immunogenicity of its biosimilar candidate ABP 501 to Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis at the American College of Rheumatology Annual Meeting in San Francisco.

Very different than “generic” drugs, biosimilar drugs have the potential to offer patients broader access to known therapies called reference biologic medicines, and are being developed for many conditions. Biologics are 200 to 1,000 times the size of a small molecule (generic) drug, more structurally complex, and are made in living cells, then extracted and purified, whereas small molecule drugs and generics are manufactured purely via chemical synthesis. Biosimilars are not expected to be identical medicines to their reference biologic drug. Because biosimilars will have minor differences, both pharmacological and clinical data will be required to demonstrate that each biosimilar has safety and effectiveness that is similar to the reference biologic medicine in order to be approved by the FDA.
ABP 501 is being developed as a biosimilar candidate to Humira, an anti-TNF-α monoclonal antibody, which is approved for the treatment of inflammatory diseases, including rheumatoid and psoriatic arthritis, psoriasis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis.

This currently reported clinical study evaluated the safety and effectiveness of the biosimilar drug ABP 501 compared to Humira in adult patients with moderate-to-severe rheumatoid arthritis that had an inadequate response to methotrexate.

Patients were treated with identical doses of ABP 501 or Humira every two weeks and directly compared at several intervals. When compared to Humira, ABP 501 demonstrated similar safety, and clinical effectiveness as measured by ACR response criteria and disease activity scores.

Reference:

1. Weinblatt M, Baranauskaite A, Niebrzydowski J, et al. A Phase III, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week Results) [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). Accessed November 16, 2015.

  1. Amgen press release.
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